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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 September 2016 |
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Main ID: |
NCT02343094 |
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Date of registration:
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15/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phenylbutyrate in Proteinuric Nephropathies
PIRATE |
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Scientific title:
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Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02343094 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Bertrand KNEBELMANN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Service de Néphrologie Adulte, Hôpital Necker |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic Kidney disease for ore than 3 months
- Proteinuria > 1g/d or 0,1g/mmmol creatinine
- eGFR >30ml/mn/1,73m2
- written informed consent
- affiliated with social security health insurance
Exclusion Criteria:
- Women with childbearing potential
- Recent (<3 months) modification of ACE inhibitors or ARB
- Acute renal failure
- eGFR <30ml/mn/1,73m2
- Nephrotic syndrome (albuminélia <30g/l)
- Infection with HIV, HCV, HBV
- Liver insufficiency
- No affiliated with social security health insurance
- inclusion in another protocol of biomedical research
- risk of non-adherence to protocol and visits
- patients having a cardiac insufficiency of grade 3 or 4
- patient requiring of a strict salt-free diet
- patients under corticoids or immunosuppresseurs
- clinical intolerance in the treatment
- intolerance in the fructose, the syndrome of malabsorption glucose and galactose or a
deficit in sucrase / isomaltase
- patients treated by Probenecide
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Proteinuric Diseases
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Intervention(s)
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Drug: PBA 7,5g/d
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Drug: PBA 15g/d
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Primary Outcome(s)
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Urinary Lcn2/creatinine ratio
[Time Frame: Day 7, Day 15, Day 21, Day 28]
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Secondary Outcome(s)
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Urinary protein/creatinine ratio
[Time Frame: Day 21]
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Urinary protein/creatinine ratio
[Time Frame: Day 7]
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Urinary protein/creatinine ratio
[Time Frame: Day 15]
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Urinary protein/creatinine ratio
[Time Frame: Day 28]
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Secondary ID(s)
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2013-003924-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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